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teclistamab + daratumumab + hyaluronidase
- Development stage
- Unknown
- Lead developer
- Johnson & Johnson
- Modality
- T-cell Engagers → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes
- Administration
- Subcutaneous
01
Overview
Tecvayli + Darzalex Faspro is a subcutaneous combination regimen consisting of teclistamab (Tecvayli), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, and Darzalex Faspro, a subcutaneous formulation of the CD38-directed monoclonal antibody daratumumab co-formulated with recombinant human hyaluronidase PH20. Developed by Johnson & Johnson (Janssen), this combination works synergistically to prime and activate the immune system to eradicate multiple myeloma cells. In March 2026, the US FDA approved the combination for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. This approval was based on the Phase 3 MajesTEC-3 trial (NCT05083169), which demonstrated significant improvements in progression-free survival and overall survival compared to standard daratumumab-based regimens.
- Brand names
- Tecvayli + Darzalex Faspro
- Other names
- Tec-Darateclistamab + daratumumabteclistamab + daratumumab hyaluronidaseteclistamab and daratumumabteclistamab and daratumumab hyaluronidaseteclistamab-cqyv + daratumumab and hyaluronidase-fihj
02
Targets
BCMA (B-cell maturation antigen)CD3 (T-cell surface glycoprotein CD3)CD38 (Cluster of Differentiation 38)FcγR (Low affinity immunoglobulin gamma Fc region receptor II-c)
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